Surgical BleedingPhase 3NCT07830797
Absorbable Hemostatic Fluid Gelatin Trial
A Phase 3 study testing Absorbable Hemostatic Fluid Gelatin and Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix in people with Surgical Bleeding, run by Medprin Regenerative Medical Technologies Co., Ltd..
Trial summary
This is a multicenter, single-blind, randomized controlled, non-inferiority trial evaluating the safety and efficacy of an absorbable hemostatic fluid gelatin for surgical hemostasis. Subjects are patients undergoing elective/semi-elective surgeries in General Surgery, Orthopedics, and Gynecology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Bleeding
- What is being tested?
- Absorbable Hemostatic Fluid Gelatin and Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2026to 31 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years;
- 2. Scheduled for elective/semi-elective surgery in General Surgery, Orthopedics, or Gynecology;
- 3. Signed informed consent. (Intra-op): 1. Presence of a suitable Target Bleeding Site (TBS).
Who cannot join
- 1. Allergy to porcine gelatin or refusal of porcine-derived products;
- 2. INR>1.5 or PLT<100×10⁹/L;
- 3. Severe hepatic/renal dysfunction;
- 4. Pregnancy/lactation;
- 5. Participation in another trial within 30 days;
- 6. Unsuitable per investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Single-Blind, Randomized Controlled Clinical Trial of the Safety and Efficacy of Absorbable Hemostatic Fluid Gelatin for Surgical Hemostasis
This is a multicenter, single-blind, randomized controlled, non-inferiority trial evaluating the safety and efficacy of an absorbable hemostatic fluid gelatin for surgical hemostasis. Subjects are patients undergoing elective/semi-elective surgeries in General Surgery, Orthopedics, and Gynecology. The test group receives the investigational device, while the control group receives a marketed predicate device (SURGIFLO). The primary outcome is the 5-minute hemostasis success rate at the Target Bleeding Site (TBS).
Read the detailed description
This trial enrolls 324 participants (162 per group) across General Surgery, Orthopedics, and Gynecology, with equal allocation per specialty (108 each). Each subject has one Target Bleeding Site (TBS). After conventional hemostasis fails or is not applicable, subjects are randomized to receive either the test or control device. Time from product application (T0) to hemostasis (TF) is recorded. Postoperative follow-up extends to 4 months, assessing adverse events, drainage volume, and laboratory changes.
- Conditions
- Surgical Bleeding
- Being tested
- Absorbable Hemostatic Fluid Gelatin, Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix
- Keywords
- Hemostasis, Absorbable Gelatin, Fluid Gelatin, Surgical Hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable Hemostatic Fluid GelatinDevice
Composed of fluid gelatin preloaded in a syringe with catheter components; gelatin derived from porcine skin. Applied to TBS and covered with moist gauze during surgery.
Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic MatrixDevice
This product is a flowable hemostatic material made from a porcine skin-derived gelatin matrix, intended to control bleeding from capillaries, veins, and small arteries during surgical procedures
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Hemostatic Fluid Gelatin | Experimental | Composed of fluid gelatin preloaded in a syringe with catheter components; gelatin derived from porcine skin. Applied to TBS and covered with moist gauze during surgery. Receives: Device: Absorbable Hemostatic Fluid Gelatin |
| SURGIFLO™ Hemostatic Matrix | Active comparator | This product is a flowable hemostatic material made from a porcine skin-derived gelatin matrix, intended to control bleeding from capillaries, veins, and small arteries during surgical procedures Receives: Device: Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-Minute Hemostasis Success Rate
Measured: Intraoperative (Day of surgery)
Secondary outcomes (4)
3-Minute Hemostasis Success Rate
Measured: Intraoperative (Day of surgery)
Wound Hemostasis Time (T)
Measured: Intraoperative (Day of surgery)
Total Postoperative Drainage Volume
Measured: Perioperative period (time from end of surgery to patient's removal of drainage tube)
Device Usability Evaluation
Evaluate device usability on the day of surgery. Evaluation items include: 1. Convenience of device assembly; 2. Convenience of product use; 3. Wound adhesion quality; 4. Wound applicability (evaluating applicability across different wound types, such as diffuse bleeding wounds, irregular wounds, and deep cavity wounds, etc.). A 1-5 scoring scale is used: 5=Excellent, 4=Good, 3=Fair, 2=Poor, 1=Very Poor/Unacceptable. Items scoring <3 (Poor, Very Poor, Unacceptable) require special attention, and the reasons must be documented.
Measured: Intraoperative (Day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start8 Sep 2026 (estimated)
- Primary completion8 Sep 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Southern Medical University, China, Xi'an Honghui Hospital, The Third Affiliated Hospital of Southern Medical University, Obstetrics & Gynecology Hospital of Fudan University, Zhejiang Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830797
- Sponsor's protocol ID
- MP-CTP-ZXJ2026-02
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Blind, Randomized Controlled Clinical Trial of the Safety and Efficacy of Absorbable Hemostatic Fluid Gelatin for Surgical Hemostasis
- ClinicalTrials.gov ID
- NCT07830797
- Acronym / sponsor ID
- MP-CTP-ZXJ2026-02
- Conditions
- Surgical Bleeding
- Keywords
- Hemostasis, Absorbable Gelatin, Fluid Gelatin, Surgical Hemostasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Southern Medical University, China, Xi'an Honghui Hospital, The Third Affiliated Hospital of Southern Medical University, Obstetrics & Gynecology Hospital of Fudan University, Zhejiang Provincial People's Hospital
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- 8 Sep 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, single-blind, randomized controlled, non-inferiority trial evaluating the safety and efficacy of an absorbable hemostatic fluid gelatin for surgical hemostasis. Subjects are patients undergoing elective/semi-elective surgeries in General Surgery, Orthopedics, and Gynecology. The test group receives the investigational device, while the control group receives a marketed predicate device (SURGIFLO). The primary outcome is the 5-minute hemostasis success rate at the Target Bleeding Site (TBS).
Detailed description
This trial enrolls 324 participants (162 per group) across General Surgery, Orthopedics, and Gynecology, with equal allocation per specialty (108 each). Each subject has one Target Bleeding Site (TBS). After conventional hemostasis fails or is not applicable, subjects are randomized to receive either the test or control device. Time from product application (T0) to hemostasis (TF) is recorded. Postoperative follow-up extends to 4 months, assessing adverse events, drainage volume, and laboratory changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable Hemostatic Fluid Gelatin | Experimental | Device: Absorbable Hemostatic Fluid GelatinComposed of fluid gelatin preloaded in a syringe with catheter components; gelatin derived from porcine skin. Applied to TBS and covered with moist gauze during surgery. |
| SURGIFLO™ Hemostatic Matrix | Active comparator | Device: Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic MatrixThis product is a flowable hemostatic material made from a porcine skin-derived gelatin matrix, intended to control bleeding from capillaries, veins, and small arteries during surgical procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Age ≥18 years;
- 2. Scheduled for elective/semi-elective surgery in General Surgery, Orthopedics, or Gynecology;
- 3. Signed informed consent. (Intra-op): 1. Presence of a suitable Target Bleeding Site (TBS).
Key exclusion criteria (6 listed)
- 1. Allergy to porcine gelatin or refusal of porcine-derived products;
- 2. INR>1.5 or PLT<100×10⁹/L;
- 3. Severe hepatic/renal dysfunction;
- 4. Pregnancy/lactation;
- 5. Participation in another trial within 30 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable Hemostatic Fluid GelatinComposed of fluid gelatin preloaded in a syringe with catheter components; gelatin derived from porcine skin. Applied to TBS and covered with moist gauze during surgery. | Device | Absorbable Hemostatic Fluid Gelatin |
| Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic MatrixThis product is a flowable hemostatic material made from a porcine skin-derived gelatin matrix, intended to control bleeding from capillaries, veins, and small arteries during surgical procedures | Device | SURGIFLO™ Hemostatic Matrix |
Primary outcome
5-Minute Hemostasis Success Rate
Time frame: Intraoperative (Day of surgery)
4 secondary outcomes
3-Minute Hemostasis Success Rate
Time frame: Intraoperative (Day of surgery)
Wound Hemostasis Time (T)
Time frame: Intraoperative (Day of surgery)
Total Postoperative Drainage Volume
Time frame: Perioperative period (time from end of surgery to patient's removal of drainage tube)
Device Usability Evaluation
Time frame: Intraoperative (Day of surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Surgical Bleeding
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Not yet recruiting
Adjunctive Diode Laser Therapy for Peri-Implant Mucositis
Peri-implant Mucositis
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Absorbable Hemostatic Fluid Gelatin and Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix in people with Surgical Bleeding, run by Medprin Regenerative Medical Technologies Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuchuan Zhang (+86 18666661546, zhangyuchuan@medprin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-Minute Hemostasis Success Rate (time frame: Intraoperative (Day of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.